Pharmacovigilance Manager

Site Name: Athens HQ Posted Date: Jun 29 2022 Be You’ at GSK At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realize that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process. We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us. As a modern employer, we empower you to be yourself, share ideas and work collaboratively. Job Title: Pharmacovigilance Manager The PV Manager has overall oversight for safety activities under local responsibility and acts as the Local Person Responsible for Pharmacovigilance in GSK Greece. Your Responsibilities: Act as the Contact Person for Pharmacovigilance with the National Regulatory Authority/ concerned bodies, as required by the local legislation. Serve as the Local Operating Company point of contact for all safety related issues and liaise with the relevant Central Safety departments (CSD), GSK Greece departments and 3rd parties, as required. Have overall responsibility for the day-to-day management of the pharmacovigilance activities under local responsibility for all marketed products and products in clinical trials. This includes ensuring adequate systems and processes are in place to comply with local regulations and GSK global pharmacovigilance requirements. Be the local point of contact for the MAPS (Medical Information & Pharmacovigilance Regional Services) team responsible to communicate GSK local activities and escalate any identified issues related to Safety and Medical Information activities in an appropriate manner. Act as the contact person for Pharmacovigilance inspections and audits in GSK Greece. Ensure local Risk Minimization Measures are implemented locally Manage the initiation of the SDE agreements for local licensing agreements, in conjunction with legal, as appropriate and ensure all local deals are entered into the appropriate GSK database. Ensure appropriate local SOPs and guidelines are in place. Monitor the local regulations and inform Central Safety. Keep the relevant Local Operating Company and Central Safety departments informed of Pharmacovigilance requirements, emerging issues and new information concerning Pharmacovigilance. Support the Local Operating Company departments in safety issues where required and build-up a qualified drug safety/Pharmacovigilance in-house competence Provide training to all operating company staff and 3rd parties according to their specific role. LOC Quality Council – support and attend the LOC Quality Council meetings. Participate to the Pharmacovigilance working group of SFEE as GSK representative. Together with Country Medical Director, support the GM oversight of Enterprise Patient Safety Risk including review at local RMCB (Risk Management & Compliance Board) Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Minimum 2 years’ experience as Pharmacovigilance Manager or 5 years as Pharmacovigilance Officer University degree or combination with postgraduate diploma of minimum 4 years attendance in Pharmacy, Medicine, Dentistry, Biochemistry or Biology Knowledge of Greek pharmacovigilance regulations for investigational and post-marketing requirements EU resident Excellent command of Greek and English language Preferred Qualifications: Good communication skills, both oral and written Experience with supporting training Experience with supporting audits and inspections Inclusion & Diversity at GSK: Inclusion and diversity at GSK are key for our success. 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